Our client is a global leader in the Pharmaceutical and Biologics space, committed to bringing Better Health and a Brighter Future to people worldwide. They have a presence in 80 countries and regions worldwide, with over 200 years of experience. They are seeking a Principal Scientist - Technical Operations to join the team at their Dublin City Centre facility.
This is a rare and exciting opportunity - there is an excellent daily rate on offer for this long-term contract (end date 30th December 2024).
- Key technical CMO contact to support commercial production of drug products
- Provide technical expertise within the organization relating to manufacturing technology and sciences for drug product manufacturing at CMOs
- Ensure consistent supply of commercial drug products within the Europe portfolio
- Responsible for technical management of commercial production for a defined portfolio of pharmaceutical drug products and CMOs
- Collaborative resolution of technical issues related to drug product manufacturing encountered at CMOs and product quality issues to ensure uninterrupted product supply
- Management and execution of IQ/OQ/PQ/MQ protocols, site level tech transfer, continuous improvement activities, and other technical projects at CMOs
- Support process optimization and improvement activities within department and towards the CMOs
- Support launch of existing products in new markets and launch of new in-licensed products
- Writing and compilation of CMC documents including processing in the CMC document system in cooperation with Regulatory Affairs
- Degree in Pharmacy, Chemistry, Biology, Process Engineering or equivalent
- 5+ years of experience in project management, production, QA and/or QC within the pharmaceutical industry
- Good knowledge of GMP and regulatory requirements regarding manufacture of medicinal products.
- Knowledge of commercial pharmaceutical manufacturing processes and technologies (i.e. oral solid dosage and/or parenteral dosage forms)
- General understanding of pharmaceutical business (incl. technical pharmaceutical knowledge, regulatory, legal and commercial aspects)
- Experience in collaboration with contract manufacturing organizations
- Ability to solve complex situations and problems in a results-oriented manner
- Good collaboration and communication skills, team player
- Proactive, capable of efficient planning and prioritization of relevant tasks
- Cultural awareness: ability to build good relationships across cultures internally and externally, nationally and internationally
- Fluency in verbal and written English
To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 91 782 113 for a confidential discussion.